(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

NCT ID: NCT00673205

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3588 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-09-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

Detailed Description

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Conditions

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Non-Metastatic Prostate Cancer

Keywords

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androgen antagonists prostate neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

B

Group Type ACTIVE_COMPARATOR

Bicalutamide

Intervention Type DRUG

150mg p.o. daily

Interventions

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Bicalutamide

150mg p.o. daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Casodex

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Manfred P Wirth, Professor

Role: PRINCIPAL_INVESTIGATOR

Technical University of Dresden, Germany

Locations

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Research Site

Wooloongabba, Queensland, Australia

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East Melbourne, Victoria, Australia

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Graz, , Austria

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Linz, , Austria

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Mistelbach, , Austria

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Oberwart, , Austria

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Sankt Pölten, , Austria

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Antwerp, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Mons, , Belgium

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Ostend, , Belgium

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Seraing, , Belgium

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Brno, , Czechia

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Berlin, , Germany

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Bonn, , Germany

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Dresden, , Germany

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Freiburg im Breisgau, , Germany

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Heidelberg, , Germany

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Jena, , Germany

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Lübeck, , Germany

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Lüdenscheid, , Germany

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Mannheim, , Germany

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München, , Germany

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Regensburg, , Germany

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Sigmaringen, , Germany

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Budapest, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Dublin, , Ireland

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Haifa, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Bari, BA, Italy

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Bergamo, BG, Italy

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Belluno, BL, Italy

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Bologna, BO, Italy

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Brescia, BS, Italy

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Como, CO, Italy

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Cesena, FO, Italy

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Anagni, FR, Italy

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Carpi, MO, Italy

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Fidenza, PR, Italy

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Roma, Roma, Italy

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Siena, SI, Italy

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Torino, TO, Italy

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Treviso, TV, Italy

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Udine, UD, Italy

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Varese, VA, Italy

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Dolo, VE, Italy

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Portogruaro, VE, Italy

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México, , Mexico

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Capelle aan den IJssel, , Netherlands

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Gouda, , Netherlands

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Heerlen, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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Roosendaal, , Netherlands

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Rotterdam, , Netherlands

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Spijkenisse, , Netherlands

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Utrecht, , Netherlands

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Warsaw, , Poland

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Wroclaw, , Poland

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Almada, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Vila Nova de Gaia, , Portugal

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Somerset West, Cape Town, South Africa

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Bloemfontein, South Africa, South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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George, , South Africa

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Johannesburg, , South Africa

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Pietermarizberg, , South Africa

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Pretoria, , South Africa

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Granada, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Bilbao, Basque Country, Spain

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Salamanca, Castille and León, Spain

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Guadalajara, Castille-La Mancha, Spain

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Badalona(barcelona), Catalonia, Spain

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Barcelona, Catalonia, Spain

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Hospitalet de Llobregat(barcel, Catalonia, Spain

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A Coruña, Galicia, Spain

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Vigo(pontevedra), Galicia, Spain

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Alcalá de Henares, Madrid, Spain

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Getafe, Madrid, Spain

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Madrid, Madrid, Spain

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Pamplona, Navarre, Spain

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Oviedo, Principality of Asturias, Spain

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San Juan(alicante), Valencia, Spain

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Valencia, Valencia, Spain

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Reading, Berkshire, United Kingdom

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Colchester, Essex, United Kingdom

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Barnet, Hertfordshire, United Kingdom

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Tooting, London, United Kingdom

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Belfast, Northern Ireland, United Kingdom

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Taunton, Somerset, United Kingdom

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Gwent, South Wales, United Kingdom

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Eastbourne, Sussex, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Bolton, , United Kingdom

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Bristol, , United Kingdom

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Cardiff, , United Kingdom

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Cleveland, , United Kingdom

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Edinburgh, , United Kingdom

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Falkirk, , United Kingdom

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Hull, , United Kingdom

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Kent, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Plymouth, , United Kingdom

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Sheffield, , United Kingdom

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Shrewsbury, , United Kingdom

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Countries

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Australia Austria Belgium Czechia Germany Hungary Ireland Israel Italy Mexico Netherlands Poland Portugal South Africa Spain United Kingdom

References

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Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x.

Reference Type DERIVED
PMID: 22129214 (View on PubMed)

Other Identifiers

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7054IL/0024

Identifier Type: -

Identifier Source: secondary_id

D6876C00024

Identifier Type: -

Identifier Source: org_study_id